Clinical trial · Interventional
Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors
NCT00003514CI-TRIAL-00011303withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells. PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Islet Cell Carcinoma | Pancreatic Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Merkel Cell Carcinoma | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alternative product therapy | Procedure | — | UNRESOLVED |
| antineoplaston A10 | Drug | — | UNRESOLVED |
| antineoplaston AS2-1 | Drug | — | UNRESOLVED |
| biologically based therapies | Procedure | — | UNRESOLVED |
| biological therapy | Procedure | — | UNRESOLVED |
| cancer prevention intervention | Procedure | — | UNRESOLVED |
| complementary and alternative therapy | Procedure | — | UNRESOLVED |
| differentiation therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria: * Metastatic disease * Disease that is not curable with surgery or radiotherapy * Measurable disease by MRI or CT scan * Tumor must be at least 2 cm PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 2 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * No hepatic insufficiency * Bilirubin no greater than 2.5 mg/dL * SGOT and SGPT no greater than 5 times upper limit of normal Renal: * No renal insufficiency * Creatinine no greater than 2.5 mg/dL * No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: * No uncontrolled hypertension * No history of congestive heart failure * No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: * No serious lung disease, such as chronic obstructive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception during and for 4 weeks after study participation * No active infection * No concurrent nonmalignant systemic disease * Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent immunomodulating agents Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * At least 8 weeks since prior radiotherapy Surgery: * Recovered from prior surgery Other: * Prior cytodifferentiating agents allowed * No prior antineoplastons * No other concurrent antineoplastic agents
References
Publications (0)
Data not yet available
No reference posted for this study.